Rotary die system

ABSTRACT

A rotary die system that includes first and second axially aligned, coacting rotary dies positioned adjacent one another. Each die includes a working surface having a plurality of recesses defined therein. The recesses in the first die are each configured to align with a recess in the second die to form a product cavity upon coaction of the first and second dies. The product cavity is configured to receive a product. Each recess in at least one of the first or second dies includes a pin therein that is configured to puncture a film that at least partially surrounds the product.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of and claims priority to U.S. patentapplication Ser. No. 14/286,850, filed May 23, 2014, titled “Rotary DieSystem,” which claims priority under 35 U.S.C. §119 to U.S. ProvisionalApplication No. 61/826,897, filed May 23, 2013, titled “Casegel ReleaseTechnology.” The entirety of the above-identified priority applicationsare incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to a compressed tablet or caplet havinggelatin with an opening therein added to the outside surface thereofwith a rotary die system.

BACKGROUND OF THE INVENTION

The pharmaceutical, vitamin and related industries have long usedvarious ways to present their products to users in swallowable oraldosage forms, other than purely as liquids, so that persons using suchproducts can use them conveniently and comfortably. Broadly, orally usednon-liquid medicines and the like are provided in two general forms. Oneform is a tablet in which the dosage unit is a solid, hard swallowableshape comprised of the desired active ingredients compressed and formedwith suitable binders into an integral article. Tablets, in theirbroadest sense, are available in many shapes and sizes. The other commonsolid dosage is a capsule in which the active ingredients occur in aflowable state (powder, liquid, paste or the like) and are encased in adigestible shell of a suitable shape and form which is swallowable.Variations exist within and between these two general forms. Thus, it isknown to coat, as by dipping or spraying, tablet-type dosage units withgelatin or other materials to make them more palatable, easier toswallow, less prone to powder or to flake when handled in bottles,colored for eye appeal or identifiability, and longer lasting beforeactive ingredients degrade, among other reasons. Capsule forms of suchproducts occur as soft gelatin capsules, which commonly are of sphericalor oblate spherical shape, and as hard gelatin capsules which commonlyare of elongated round-ended cylindrical form and which are made in twopieces for assembly, with or without sealing, around the flowable fillmaterial containing the desired active ingredients. See, for example,U.S. Pat. No. 6,482,516 to Sadek, U.S. Pat. No. 5,146,730 to Sadek andU.S. Publication No. 2014/0072625 to Chidambaram, the entireties ofwhich are incorporated herein by reference. The membrane or coating ispresent to protect the inner materials and aid in consumption. However,it is advantageous for the membrane and product therein to digestquickly.

SUMMARY OF THE PREFERRED EMBODIMENTS

In accordance with a first aspect of the present invention there isprovided a rotary die system that includes first and second axiallyaligned, coacting rotary dies positioned adjacent one another. Each dieincludes a working surface having a plurality of recesses definedtherein. The recesses in the first die are each configured to align witha recess in the second die to form a product cavity upon coaction of thefirst and second dies. The product cavity is configured to receive aproduct. Each recess in at least one of the first or second diesincludes a pin therein that is configured to puncture a film that atleast partially surrounds the product. In a preferred embodiment, eachrecess in the first and second dies includes a pin therein that isconfigured to puncture a film that at least partially surrounds theproduct. Preferably, each pin is movable between a retracted positionand a deployed position. The pins are configured to puncture the filmthat at least partially surrounds the product in the deployed position.Preferably, the the pins are movable between the retracted position andthe deployed position by gravity.

In a preferred embodiment, the rotary die system further includes ahopper that has an open top and a bottom, and a sorter that has a topand a bottom. The sorter is positioned at the bottom of the hopper, andthe sorter is configured to feed product between the first and seconddies. Preferably, the rotary die system also includes at least onevacuum return tube that has first and second ends. The first endincludes a return opening therein that is positioned adjacent the top ofthe sorter and the second end is positioned adjacent the top of thehopper. The vacuum return tube is configured to move excess productsaccumulated at the top of the sorter back to the top of the hopper via avacuum. In a preferred embodiment, the rotary die system also includesan overflow brush or plug that is movable between a plugged positionwhere it blocks the return opening and the vacuum, and an unpluggedposition where it does not block the return opening and the vacuum, thusallowing excess products to be moved via the vacuum from the top of thesorter back to the top of the hopper. Preferably, the overflow brush ismovable from the plugged to the unplugged position by excess productspositioned at the top of the sorter.

In accordance with another aspect of the present invention there isprovided a method of providing an enrobed product that includesproviding first and second films, providing first and second axiallyaligned, coacting rotary dies positioned adjacent one another, andmoving the films through a place of coaction of the first and seconddies. The first and second dies include cooperating working surfacesthat include a plurality of recesses defined therein that form betweenthem, upon coaction of the dies, at least a first cavity for receivingtherein a product. The method includes dispensing a product into contactwith at least one of the first and second films at a location on the atleast one film that corresponds to the location of the first cavity, atthe place of die coaction, stretching the first and second films aroundthe product to cause the product to be enrobed by and between the firstand second films, puncturing at least one of the first and second filmswhile the product is located in the cavity, and separating the enrobedproduct from the first and second films. Preferably, the puncturing stepis performed by a pin that is movable between a retracted position and adeployed position.

In a preferred embodiment, the method includes providing a hopper havingan open top and a bottom, and a sorter having a top and a bottom that ispositioned at the bottom of the hopper. The sorter is configured to feedproduct between the first and second dies. The method includes placing aplurality of products into the hopper that fall into the sorter, andvacuuming at least one excess product from adjacent the top of thesorter back to the top of the hopper. In a preferred embodiment, themethod includes moving an overflow brush from a plugged position to anunplugged position prior to the step of vacuuming at least one excessproduct from adjacent the top of the sorter back to the top of thehopper.

In accordance with another aspect of the present invention there isprovided an enrobed product that includes a product, and first andsecond gelatin coating portions enrobing the product that are sealedtogether along a seal line encircling the product. At least one of thefirst and second coating portions includes an opening defined thereinthat exposes the product. Preferably, both the first and second coatingportions include an opening defined therein that exposes the product.

The invention, together with additional features and advantages thereof,may be best understood by reference to the following description.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of a rotary die system in accordance with apreferred embodiment of the present invention;

FIG. 2 is a front elevational view of a sorter that is part of therotary die system of FIG. 1;

FIG. 3 is a perspective view of the rotary die system of FIG. 1;

FIG. 4 is a cross-sectional view taken along line 4-4 of FIG. 1; and

FIG. 5 is a perspective view of an enrobed product in accordance with apreferred embodiment of the present invention.

Like numerals refer to like parts throughout the several views of thedrawings.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following description and drawings are illustrative and are not tobe construed as limiting. Numerous specific details are described toprovide a thorough understanding of the disclosure. However, in certaininstances, well-known or conventional details are not described in orderto avoid obscuring the description. References to one or an otherembodiment in the present disclosure can be, but not necessarily are,references to the same embodiment; and, such references mean at leastone of the embodiments.

Reference in this specification to “one embodiment” or “an embodiment”means that a particular feature, structure, or characteristic describedin connection with the embodiment is included in at least one embodimentof the disclosure. Appearances of the phrase “in one embodiment” invarious places in the specification do not necessarily refer to the sameembodiment, nor are separate or alternative embodiments mutuallyexclusive of other embodiments. Moreover, various features are describedwhich may be exhibited by some embodiments and not by others. Similarly,various requirements are described which may be requirements for someembodiments but not other embodiments.

The terms used in this specification generally have their ordinarymeanings in the art, within the context of the disclosure, and in thespecific context where each term is used. Certain terms that are used todescribe the disclosure are discussed below, or elsewhere in thespecification, to provide additional guidance to the practitionerregarding the description of the disclosure. For convenience, certainterms may be highlighted, for example using italics and/or quotationmarks: The use of highlighting has no influence on the scope and meaningof a term; the scope and meaning of a term is the same, in the samecontext, whether or not it is highlighted. It will be appreciated thatthe same thing can be said in more than one way.

Consequently, alternative language and synonyms may be used for any oneor more of the terms discussed herein. Nor is any special significanceto be placed upon whether or not a term is elaborated or discussedherein. Synonyms for certain terms are provided. A recital of one ormore synonyms does not exclude the use of other synonyms. The use ofexamples anywhere in this specification including examples of any termsdiscussed herein is illustrative only, and is not intended to furtherlimit the scope and meaning of the disclosure or of any exemplifiedterm. Likewise, the disclosure is not limited to various embodimentsgiven in this specification.

Without intent to further limit the scope of the disclosure, examples ofinstruments, apparatus, methods and their related results according tothe embodiments of the present disclosure are given below. Note thattitles or subtitles may be used in the examples for convenience of areader, which in no way should limit the scope of the disclosure. Unlessotherwise defined, all technical and scientific terms used herein havethe same meaning as commonly understood by one of ordinary skill in theart to which this disclosure pertains. In the case of conflict, thepresent document, including definitions, will control.

It will be appreciated that terms such as “front,” “back,” “top,”“bottom,” “side,” “short,” “long,” “up,” “down,” and “below” used hereinare merely for ease of description and refer to the orientation of thecomponents as shown in the figures. It should be understood that anyorientation of the components described herein is within the scope ofthe present invention.

In broad terms, this invention concerns the coating of tablets, othersolid dosage forms, and a variety of solids by enrobement with films ofgelatin or other sealable polymers by an enrobement process which usescoacting die techniques in which the tablets or other articles to beenrobed are introduced individually between two sealable filmspositioned between opposing matching dies configured to cause the filmsto stretch and deform around each introduced article so that the filmsmove into contact with each other, are sealed to each other and, assealed, are severed from the film webs to provide individualfilm-enrobed end products. The particular product which formed the focusof the development of this invention is a tablet of caplet configurationenrobed between applied gelatin films which adhere to the solid tabletproduct to produce a non-peelable, tamper-evident and potentiallytamper-resistant gelatin coated caplet-type medicine tablet.

The hermetically-sealed applied-film coating around the tablet or othersolid core of the enrobed product can be treated after production forcontrolled release or enteric release. Due to the continuous nature ofthe applied-film coating, individual coated units provide an assuranceof consistent product performance.

In the following description, unless the usage context indicatesotherwise, the term “tablet” is used in its broad sense to mean a solid,hard, unitary pellet containing one or more active ingredients, whichpellet is of such size as to be administered by an intended user and isof desired geometry; the term includes such things having capletconfiguration, which things are often referred to simply as “caplets”.

FIGS. 1-5 show a rotary die system 10 that provides a compressed tabletor caplet 100 having a gelatin coating 102 thereon and that includes atleast one opening 104 in the coating. Generally, the material (e.g.,tablet or caplet) that is enrobed by the gelatin coating 102 is referredto herein as the “product” 100 and the product together with the gelatincoating 102 is referred to herein as the enrobed product 106. Theenrobed product 106 (best shown in FIG. 5) includes the product and ahard gelatin coating 102 that fully encloses the product 100. Thegelatin coating 102 conforms tightly to the contours of the product 100and is adhered tightly to the surfaces of the product 100 over theentire exterior thereof. The gelatin coating 102 is comprised ofpreferably first and second coating portions 102 a and 102 b of softelastic gelatin that are applied to opposite sides of the product 106,each include an opening 104 therein, and are sealed together, in anessentially edge-to-edge manner, along a seal line 107 that encirclesthe product 100 to create the enrobed product 106.

As shown in FIG. 1, in a preferred embodiment, the rotary die system 10generally includes first and second dies 12 that are each configured torotate about an axis, a hopper 16, a filler 18, a plurality of vacuumreturn tubes 20, a sorter 22 and an overflow brush 24. Generally, theproducts 100 are dispensed from the filler 18 and fall into the hopper16 and are gravity fed to the sorter 22, which is positioned at thebottom of the hopper 16. After being sorted by the sorter 22, theproducts 100 is dispensed on a self-timed basis into essentiallysimultaneous contact with two enrobing gelatin films or sheets 108 thatare supported on the locally recessed coacting rotary dies 12. The films108 deform around each product 100 and are sealed by the dies 12 to eachother before the dies coact to cut the enrobed products 106 from thefilms 108. In the presently preferred embodiments of the manufacturingprocess and system described herein, the product feeding mechanism(e.g., hopper 16 and sorter 22) is arranged to introduce the products100 to the films 108 in the working area between the dies 12 so thateach product 100 contacts both films 108 essentially simultaneously.

As shown in FIGS. 3-4, in a preferred embodiment, the first and seconddies 12 include a plurality of pins 26 that are positioned in recesses28 that are defined in an outer working surface 30 of each of the dies12. In use, the pins 26 prick the film 108 and provide an opening 104 inresulting coating 102 in the enrobed product 106, as shown in FIG. 5. Itwill be appreciated that each of the recesses 28 in the working surface30 of a die 12 cooperates with a corresponding recess 28 in the otherdie 12 for defining a corresponding cavity between the dies 12 as theyturn about their axes of rotation into and out of substantially matchingcoaction with each other. The cavities defined by cooperation of therespective recesses 28 are sized and shaped to loosely receive in eachcavity a single product 100.

In a preferred embodiment, each pin 26 is movable between a retracted orfirst position, where the pin 26 is retracted into the die 12, and adeployed or second position, where the pin 26 is in position to prickthe film 108 to form opening 104. In a preferred embodiment, the pins 26are movable between the retracted and deployed positions via gravity. Inanother embodiment, the pins can be deployed via centrifugal force. Inthe retracted position, the pins 26 are positioned in openings 31 at thebottom of each recess 28. In use, as the dies rotate the pin 26 pushesthrough the gelatin 102 to produce the opening 104. In a preferredembodiment, as the gelatin 102 dries the opening 104 expands due to theloss of moisture in the gelatin 102.

In a preferred embodiment, the die system 10 includes the vacuum returntubes 20, and overflow brush 24, as discussed above. During processingthere may at times be an excess overflow of products 100 into the hopper16 and to the sorter 22. Essentially, there may be a point where thesorter 22 cannot handle the amount of products 100. The sorter 22preferably includes a manifold 32. To prevent clogging of the manifold32, the overflow brush 24 and vacuum return tubes 20 cooperate to moveproducts 100 from the bottom of the hopper 16 back to the top. FIG. 2shows the sorter 22 full of products 100. If more products 100 come downon top of the full sorter 22, the overflow brush 24 is pushed upwardly,which unblocks the vacuum return tubes 20 (see return openings 34).Essentially, overflow brush 24 acts as a plug. Therefore, once overflowbrush 24 is moved upwardly, the vacuum within vacuum return tubes 20pulls the excess products 100 through the tubes and reenters theproducts 100 into the top of the hopper 16.

FIG. 5 shows an enrobed product 106, that includes openings 104 in thecoating 102 on the outside thereof. It will be appreciated by those ofordinary skill in the art that when a person ingests the enrobed product106 and the acid in the stomach enters the opening 104 and reaches theproduct 100, the product 100 expands and the gelatin 102 ruptures. In anexemplary embodiment, this allows for the product 100 to be releasedwithin about ten minutes of ingestion.

Unless the context clearly requires otherwise, throughout thedescription and the claims, the words “comprise,” “comprising,” and thelike are to be construed in an inclusive sense, as opposed to anexclusive or exhaustive sense; that is to say, in the sense of“including, but not limited to.” As used herein, the terms “connected,”“coupled,” or any variant thereof, means any connection or coupling,either direct or indirect, between two or more elements; the coupling ofconnection between the elements can be physical, logical, or acombination thereof. Additionally, the words “herein,” “above,” “below,”and words of similar import, when used in this application, shall referto this application as a whole and not to any particular portions ofthis application. Where the context permits, words in the above DetailedDescription of the Preferred Embodiments using the singular or pluralnumber may also include the plural or singular number respectively. Theword “or” in reference to a list of two or more items, covers all of thefollowing interpretations of the word: any of the items in the list, allof the items in the list, and any combination of the items in the list.

The above-detailed description of embodiments of the disclosure is notintended to be exhaustive or to limit the teachings to the precise formdisclosed above. While specific embodiments of and examples for thedisclosure are described above for illustrative purposes, variousequivalent modifications are possible within the scope of thedisclosure, as those skilled in the relevant art will recognize. Forexample, while processes or blocks are presented in a given order,alternative embodiments may perform routines having steps, or employsystems having blocks, in a different order, and some processes orblocks may be deleted, moved, added, subdivided, combined, and/ormodified to provide alternative or subcombinations. Each of theseprocesses or blocks may be implemented in a variety of different ways.Also, while processes or blocks are at times shown as being performed inseries, these processes or blocks may instead be performed in parallel,or may be performed, at different times. Further any specific numbersnoted herein are only examples: alternative implementations may employdiffering values or ranges.

The teachings of the disclosure provided herein can be applied to othersystems, not necessarily the system described above. The elements andacts of the various embodiments described above can be combined toprovide further embodiments.

Any patents and applications and other references noted above, includingany that may be listed in accompanying filing papers, are incorporatedherein by reference in their entirety. Aspects of the disclosure can bemodified, if necessary, to employ the systems, functions, and conceptsof the various references described above to provide yet furtherembodiments of the disclosure.

These and other changes can be made to the disclosure in light of theabove Detailed Description of the Preferred Embodiments. While the abovedescription describes certain embodiments of the disclosure, anddescribes the best mode contemplated, no matter how detailed the aboveappears in text, the teachings can be practiced in many ways. Details ofthe system may vary considerably in its implementation details, whilestill being encompassed by the subject matter disclosed herein. As notedabove, particular terminology used when describing certain features oraspects of the disclosure should not be taken to imply that theterminology is being redefined herein to be restricted to any specificcharacteristics, features or aspects of the disclosure with which thatterminology is associated. In general, the terms used in the followingclaims should not be construed to limit the disclosures to the specificembodiments disclosed in the specification unless the above DetailedDescription of the Preferred Embodiments section explicitly defines suchterms. Accordingly, the actual scope of the disclosure encompasses notonly the disclosed embodiments, but also all equivalent ways ofpracticing or implementing the disclosure under the claims.

Accordingly, although exemplary embodiments of the invention have beenshown and described, it is to be understood that all the terms usedherein are descriptive rather than limiting, and that many changes,modifications, and substitutions may be made by one having ordinaryskill in the art without departing from the spirit and scope of theinvention.

What is claimed is:
 1. A rotary die system comprising: first and secondaxially aligned, coacting rotary dies positioned adjacent one another,wherein each die includes a working surface having a plurality ofrecesses defined therein, wherein the recesses in the first die are eachconfigured to align with a recess in the second die to form a productcavity upon coaction of the first and second dies, wherein the productcavity is configured to receive a product, wherein each recess in atleast one of the first or second dies includes a pin therein that isconfigured to puncture a film that at least partially surrounds theproduct.
 2. The rotary die system of claim 1 wherein each recess in thefirst and second dies includes a pin therein that is configured topuncture a film that at least partially surrounds the product.
 3. Therotary die system of claim 2 wherein each pin is movable between aretracted position and a deployed position, wherein the pins areconfigured to puncture the film that at least partially surrounds theproduct in the deployed position.
 4. The rotary die system of claim 3wherein the pins are movable between the retracted position and thedeployed position by gravity.
 5. The rotary die system of claim 1further comprising a hopper having an open top and a bottom, and asorter having a top and a bottom, wherein the sorter is positioned atthe bottom of the hopper, and wherein the sorter is configured to feedproduct between the first and second dies.
 6. The rotary die system ofclaim 5 further comprising at least one vacuum return tube having firstand second ends, wherein the first end includes a return opening thereinthat is positioned adjacent the top of the sorter and the second end ispositioned adjacent the top of the hopper, and wherein the vacuum returntube is configured to move excess products accumulated at the top of thesorter back to the top of the hopper via a vacuum.
 7. The rotary diesystem of claim 6 further comprising an overflow brush that is movablebetween a plugged position where it blocks the return opening and thevacuum, and an unplugged position where it does not block the returnopening and the vacuum, thus allowing excess products to be moved viathe vacuum from the top of the sorter back to the top of the hopper. 8.The rotary die system of claim 7 wherein the overflow brush is movablefrom the plugged to the unplugged position by excess products positionedat the top of the sorter.
 9. A method of providing an enrobed product,the method comprising the steps of: (a) providing first and secondfilms, (b) providing first and second axially aligned, coacting rotarydies positioned adjacent one another, (c) moving the films through aplace of coaction of the first and second dies, the first and seconddies having cooperating working surfaces that include a plurality ofrecesses defined therein that form between them, upon coaction of thedies, at least a first cavity for receiving therein a product, (d)dispensing a product into contact with at least one of the first andsecond films at a location on the at least one film that corresponds tothe location of the first cavity, (e) at the place of die coaction,stretching the first and second films around the product to cause theproduct to be enrobed by and between the first and second films, (f)puncturing at least one of the first and second films while the productis located in the cavity, and (g) separating the enrobed product fromthe first and second films.
 10. The method of claim 9 wherein step (f)is performed by a pin that is movable between a retracted position and adeployed position.
 11. The method of claim 10 wherein the pin is movablebetween the retracted position and the deployed position by gravity. 12.The method of claim 9 further comprising the steps of providing a hopperhaving an open top and a bottom, and a sorter having a top and a bottom,wherein the sorter is positioned at the bottom of the hopper, andwherein the sorter is configured to feed product between the first andsecond dies, wherein the method further comprises the steps of placing aplurality of products into the hopper that fall into the sorter, andvacuuming at least one excess product from adjacent the top of thesorter back to the top of the hopper.
 13. The method of claim 12 furthercomprising the step of moving an overflow brush from a plugged positionto an unplugged position prior to the step of vacuuming at least oneexcess product from adjacent the top of the sorter back to the top ofthe hopper.
 14. An enrobed product comprising a product, and first andsecond gelatin coating portions enrobing the product that are sealedtogether along a seal line encircling the product, wherein at least oneof the first and second coating portions includes an opening definedtherein that exposes the product.
 15. The enrobed product of claim 14wherein both the first and second coating portions include an openingdefined therein that exposes the product.